FDA Warns Consumers about Counterfeit Alli Containing Sibutramine

Alli, the reduced-strength version of GlaxoSmithKline’s orlistat (Xenical), is an approved over-the-counter weight-loss drug for overweight adults 18 years and older. Xenical is prescription only.

The U.S. Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by Glaxo revealed that the counterfeit version does not contain orlistat, but instead contained the controlled substance sibutramine.

Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss. It can substantially increase blood pressure and heart rate. This potent drug poses a significant health risk for anyone with a history of heart disease, heart failure, heart arrhythmias (irregular heart beats ), or stroke.

Glaxo began getting consumers reports of suspected counterfeit Alli in early December 2009. The counterfeit product has been sold over the internet. At this time, there is no evidence that the counterfeit Alli product has been sold through other channels, such as retail stores.

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The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

Outer cardboard packaging missing a “Lot” code;

Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);

Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;

Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;

Contains larger capsules with a white powder, instead of small white pellets.

Alli is meant to be used in conjunction with a low-calorie, low-fat diet and regular exercise. Alli works by disabling lipase, which prevents the enzyme from breaking down the fat while it's in the digestive tract. The undigested fat continues through the intestines and is eliminated through bowel movements.

Alli is taken with fat-containing meals, up to three times a day. Because of how Alli works, it's recommended that you eat no more than 15 grams of fat with each meal. Eating higher amounts of fat can cause unwanted effects, such as urgent bowel movements, diarrhea and gas with oily spotting.

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Pictures of counterfeit Alli samples provided by GSK can be seen on the FDA website here.